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Clinical Trial to Reduce Antibiotic Resistance in European Intensive Cares

NCT00976638 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14318

Last updated 2012-08-06

No results posted yet for this study

Summary

Colonization of patients with Antimicrobial Resistant Bacteria (AMRB) like Methicillin Resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and Extended-Spectrum Beta-Lactamases (ESBL) enterobacteriaceae leads to infections; and ultimately to adverse outcomes (eg prolonged hospital stay, death). This is an urgent problem in Europe, especially in Intensive Care Units (ICUs).

In this trial, colonization of patients with these AMRB will be assessed in the baseline period (6m). In phase 2 the effect of a Hygiene Improvement Program, including Chlorhexidine body washings and a Hand Hygiene training program, will be assessed (6m). In phase 3 units will be randomized to either Active Surveillance with Chromagar based tests or a Molecular based tests.

Study Hypothesis: the abovementioned interventions will reduce ICU-acquired colonization rates with MRSA, VRE and ESBL.

Conditions

  • Hospital Acquired Infections

Interventions

OTHER

Chromogenic surveillance

All admitted patients are screened on admission for MRSA and VRE by chromogenic agar and isolated when positive

OTHER

Molecular surveillance

All patients are screened for MRSA and VRE by PCR; and for ESBL by chromogenic agar on admission. Positive patients are isolated

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Marc Bonten, Prof, MD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • France
  • Greece
  • Italy
  • Latvia
  • Luxembourg
  • Portugal
  • Slovenia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00976638 on ClinicalTrials.gov